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NCT00333112 Clinical Trial

A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.

Urinary Incontinence Clinical Trial

— VICTOR  

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Frequency in Men VICTOR: VESIcare® In Combination With Tamsulosin in OAB Residual Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333112
Other study ID # 905-UC-008
Secondary ID
Status Completed
Phase Phase 4
First received June 1, 2006
Last updated September 17, 2014
Start date May 2006
Est. completion date January 2007

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.

Description:

A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men

Recruitment information / eligibility
Status Completed
Enrollment 398
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

- Current use of antimuscarinic therapy

- Evidence of a urinary tract infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• solifenacin succinate
Oral
• tamsulosin
oral
• placebo
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in micturitions per 24 hours from baseline to end of treatment 18 weeks No
Secondary Change in urgency episodes per 24 hours from baseline to end of treatment 18 weeks No
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